Puberty Blockers clinical trial.

[PlainJane999]

Simple question, do those here support the prescription of blockers as part of a clinical trial and why?

Puberty is a human right! No child should have their puberty blocked it's disgusting that it is happening at all.

I do not, as it appears entirely counter to the welfare of children to prescribe a pharmacutical for physical alterations, for a psychological/psychiatric condition

No.

They have been 'trialling' this for nearly 30 years and have no beneficial evidence so far. They only managed to get this through any 'ethics' trials by meddling with the scales to gauge 'success', deliberately restricted the follow ups, changed the ages their approval was originally for, and have buried any long term studies presumably because there is no evidence of benefits.

I don't think we should subject a whole new generation to the same manipulative behvaviour. These people cannot be trusted.

The whole thing should be shut down immediately.

No more children should be harmed in order to provide cover for a male sexual fetish.

Agree. At the end of the day I can do nothing to prevent this but I would have very serious concerns about it and would hope they have to go through very stringent ethical approval. Long term use of these drugs have lifelong consequences that children cannot meaningfully consent to.

I asked this question because it is a key recommendation of the Cass Review. I would appreciate it if people could reference this in their answers. My understanding is that this forum broadly supports the Cass Review, yet the initial answers seem to suggest otherwise.

What a disingenuous attempt at a gotcha. I agree with the broad principles of the Cass Review and my understanding was that puberty blockers for those children who may identify as "trans" should be stopped until they are shown to be more beneficial than harmful. That does not actually mean that trials are supported.

This.

The clinics who have been prescribing PBs didn't collect follow up data and didn't cooperate with Cass. As the trend has existed for some time, it should by now be possible to draw some conclusions from outcomes. It would be difficult to devise an ethical trial when there isn't a clinical need to block puberty. Could we devise an ethical clinical trial to test chemotherapy on children without cancer?

I agree in principle, but I'm not sure you could do it ethically given we're talking about kids. Around 80% of children with dysphoria do not continue into adulthood as trans, yet 98% of those put on blockers go on to to take hormones. There are going to be kids selected for that study who suffer the consequences of blockers and are funneled into a lifetime of medicalisation, when there's a good chance they would have otherwise desisted over time and retained all function, normal height, bone density, cognitive development, etc. All that stuff people who love blockers never talk about.

I saw an interesting thread on Twitter which described trials on sheep which didn't go well. (It irrevocably halted brain development) I think Dr Cass was probably completely aware that there is no possibility of an ethical trial on children. There is an excellent talk from Dr Sallie Baxendale here about the effects of puberty blockers on brain development.

As we've got a lot of resourceful, well informed and connected people on here, does anybody know about the proposed study? It's mentioned in the Cass Review (https://cass.independent-review.uk/home/publications/final-report/final-report-faqs/) but the details are a bit hazy. It's mentioned that the NIHR is involved, but it doesn't appear to be on the NIHR website yet. So I dunno what they're intending to do.

Stated baldly like that, it's hard to agree with - it sounds a bit like planning a trial of bloodletting or treating STIs with mercury. But the way the need for further investigation is phrased in Cass, it sounds more humane and informative.

The Cass review mentions that a "puberty blocker research protocol" is already in development and that a puberty blocker trial "has been taken forward by NHS England", as though this research has already started.

Given what we know about the effects of puberty blockers in adolescence followed by opposite sex hormones, how can this be ethical?

We know that the effect of this "treatment" results in infertile adults with impaired sexual function. How can any child consent to this? And how can sterilising children ever be viewed as ethical?

Maybe the OP can explain?

My thoughts are that Cass was trying to stop activists from going after her and tried to couch 'both sides' instead of saying 'actually gender dysphoria isn't a thing so stop this nonsense now'.

I thought Cass had pretty much said

a) It'd be good in a way to have a clinical trial of PB use, but there are problems ahead with ethics which might mean it won't be possible, and

b) Of course, it didn't help that the Tavi did not track all the kids they treated.

Or am I putting words in her mouth?

This is well worth watching; its just over 20 minutes long.

It is an absolute scandal that people are arguing that this so called treatment should be continued.

Yes.

A trial should be put forward that meets rigid ethical standards, including fully informed consent. If it is not considered possible for children (or parents on their behalf) to provide fully informed consent, it should follow whatever protocol is standard to halt the trial at this point.

Do I think it's possible for children (or parents on their behalf) to fully consent, when it is "not known whether hormone blockers affect the development of the teenage brain"?** No. But it would be good to see this hypothesis tested against standard medical trial protocol.

**Screenshot is from the 2021 version of the NHS advice on gender dysphoria:

<a class="break-all" href="https://archive.ph/2021.10.30-081225/www.nhs.uk/conditions/gender-dysphoria/treatment" rel="nofollow" target="_blank">https://archive.ph/2021.10.30-081225/www.nhs.uk/conditions/gender-dysphoria/treatment/

The latest version doesn't mention anything about brain development risks.... Perhaps they don't want to draw attention to it, given they prescribed puberty blockers until recently.

Clinical trial or social experiment.
I think you are asking if we are happy with the social experiment. Answer : no.

If you can define what the clinical trial is then maybe we can debate that.

Gah, the archive link didn't work very well. If you enter this page in archive.ph or similar, you can access the 2021 version from there. This is the current version, without any mention of brain development risk.

https://www.nhs.uk/conditions/gender-dysphoria/treatment/

All puberty blockers so far were given off label but if it was done 'on label' in clinical trial it would not meet the ethical guidelines.

Remember the Mayo Clinic's evidence on puberty blockers not being reversable and causing perminant sex gland atrophy has only recently emerged. This would also need to be taken into account now.

www.dailymail.co.uk/health/article-13276501/Mayo-Clinic-puberty-blockers-trans-kids-fertility-cancer-medicine.html

I’d want to see the research protocols before I’d agree or disagree (especially around side effects - ie will the trial include bone density monitoring and will the child be withdrawn from trial if negative effects are observed? and repeat for all the other side effects of GnRha that are observed in women prescribed it as part of fertility treatments/men with cancer eg brain fog, obesity, tooth loss etc) And what about gamete preservation?

in paediatric cancer care it’s very common for kids accessing unlicensed medications to be signed up to research trials - however this is usually after the first line, established treatment fails to achieve remission.

What is the first line treatment for gender dysphoria that would need to fail before the trial became accessible? How do you measure success or failure in GD treatment?

In the Cass Review it says:
"16.38 The Review has already advised that
because puberty blockers only have clearly
defined benefits in quite narrow circumstances,
and because of the potential risks to
neurocognitive development, psychosexual
development and longer-term bone health,
they should only be offered under a research
protocol. This has been taken forward by NHS
England and the National Institute for Health
and Care Research (NIHR)."
So it says that the protocol has been 'taken forward' by NHSE and NIHR but it doesn't say what it is, and it doesn't show up elsewhere on the internet to my knowledge. Seeing as quite a few people on here seem to work in research organisations or healthcare I wondered whether anyone knew anything that could be shared? The NIHR likes a lot of patient-public involvement in research designs, so there's presumably some consultation, focus groups and the like, where the proposals would be shared with the consultees for comment. But I've not seen anything.

Maybe I am missing somthing but I was reading the report and this is what triggered my question: (I have pulled out the key sentences, feel free to look at the report for full context)

Recommendation 6:

"Following our earlier recommendation to establish a puberty blocker trial, which has been taken forward by NHS England, we further recommend a full programme of research be established"

"The puberty blocker trial should be part of a programme of research which also evaluates outcomes of psychosocial interventions and masculinising/ feminising hormones"

Sorry - more or less duplicated your post @PlainJane999 We must have been typing at the same time.

The wise women of mumsnet managed to break down Aston's doings in forensic linguistics pretty quickly a while ago, so it should be possible to find out about this too.

The reason they are not ‘on label’ is because there have been no adequate clinical trials. Drug companies have to prove safety and efficacy first. They can’t.

It would not be possible to have an ethical trial for PB. The misinformation by activists alone removes any possibility of true consent.